Figure 1.

Trial design. *Inhibitor testing was performed at visits 3, 4 and 5 (10‐15, 20‐25 and 50‐55 EDs, respectively) and could be done at any unscheduled visit at the investigators’ discretion. Patients receiving on‐demand treatment were allowed to postpone initiation of their prophylaxis regimen until they had experienced either a minimum of two treatment‐requiring bleeds or once they had reached 2 y of age (whichever came first). On‐demand treatment was initiated as soon as a bleed was identified. EDs, exposure days; EOT, end of end of trial; V, visit